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FDA 510(k)

BIPOLAR TEMP. PACING CATHETER W/STYLETET

K-Number: K822002 · 1982-10-15

ApplicantZiehm International, Inc.
Decision Date1982-10-15
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIPOLAR TEMP. PACING CATHETER W/STYLETET is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1982-10-15 under 510(k) number K822002. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPOLAR TEMP. PACING CATHETER W/STYLETET?

BIPOLAR TEMP. PACING CATHETER W/STYLETET is a medical device that received FDA 510(k) clearance on 1982-10-15. The listed applicant is Ziehm International, Inc.. The 510(k) number is K822002.

When did BIPOLAR TEMP. PACING CATHETER W/STYLETET receive FDA 510(k) clearance?

BIPOLAR TEMP. PACING CATHETER W/STYLETET received FDA 510(k) clearance on 1982-10-15, under 510(k) number K822002.

Who is the listed applicant for BIPOLAR TEMP. PACING CATHETER W/STYLETET?

The FDA 510(k) record lists Ziehm International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPOLAR TEMP. PACING CATHETER W/STYLETET?

The FDA product code for BIPOLAR TEMP. PACING CATHETER W/STYLETET is LDF.

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Other records listing Ziehm International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011292ZIEHM VISIONK910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK890620STICK-GARD SAFETY NEEDLE

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Related Devices (Code: LDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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